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临床试验/CTRI/2023/07/055030
CTRI/2023/07/055030尚未招募2/3 期

An Anatomico clinical study on comparative effect of Mulbandha and Matra Basti along with Pichu Dharan in Yonibhransha with special reference to to 1st and 2nd Degree Utero-vaginal Prolapse

Dept of Rachana Sharir Faculty of Ayurveda IMS BHU Varanasi1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年4月6日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
150
试验地点
1
主要终点
decrease in symptoms

研究概览

简要总结

Women’s health is prime concern ofmedical fraternity. Therefore, modern as well as traditional medical scienceput major focus on women’s health. Indianwomen have high mortality rates, particularly during childhood and in theirreproductive years. The health of Indian women is intrinsically linked to theirstatus in society. Anatomically and physiologically reproductive system ofwomen is different from male. Women have certain anatomical changes in uterusdue to pregnancy, childbirth and in menopausal phase, make her more prone toUterine Prolapse / Utero-vaginal Prolapse.

**a.**Clinical Study

Type–Randomized Intervention Trial

Total150 patients aged 30 to 60 years from the O.P.D. / I.P.D., Department of PrasutiTantra, S.S. Hospital, BHU, Varanasi (UP) will be screened for Yonibhransha (1st and 2nd degreeutero-vaginal prolapse*)* by the consultant [co-supervisor] thenwill be allowed for registration. The consent of (1st and 2nddegree Utero-vaginal prolapse) patients will be obtained for participation inthe study then they will be registered on a predesigned proforma. Theseregistered patients will be divided into three groups randomly by using randomnumber generation in an excel sheet.  Thethree groups will be as follows: -

**GroupA (50 Cases) –**This group will have ( 1stand 2nd degree Utero-vaginal prolapse)  patients who will be advised with practicing Mulbandha standard technique.

GroupB (50 Cases) – This group will have ( 1stand 2nd degree Utero-vaginal prolapse) who will be advised with Matra Basti (Bala Taila) along with Pichu Dharan (PanchavalkalaTaila).

**GroupC (50 Cases) -**Control Group will be treated with Placebo.Placebo capsule (1BD)

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
30.00 Year(s) 至 60.00 Year(s)(—)
性别
Female

入选标准

  • 1 Feeling of something coming our per vagina 2 micturition disturbances 3 bowel disturbances 4 Backache 5 Dragging pain in pelvis 6 symptoms with 1st and 2nd degree utero vaginal prolapse.

排除标准

  • 1 age below 30 and above 60 years 2 pregnancy 3 history of psychotic diseases 4 anal fissure and haemorrhoids 5 PID and other STD 6 congenital anomalies leading to prolapse 7 3rd and 4th degree uterine prolapse.

结局指标

主要结局

decrease in symptoms

时间窗: before intervention and every month after intervention for 4 months

feeling of mass coming per vagina

时间窗: before intervention and every month after intervention for 4 months

次要结局

  • decrease in backache or dragging pain in pelvis(duration of 4 months)

研究者

发起方
Dept of Rachana Sharir Faculty of Ayurveda IMS BHU Varanasi
申办方类型
Research institution and hospital

研究点 (1)

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